All Features
Etienne Nichols
What’s your favorite regulatory pitfall? I know that’s a strange question, but if you’ve spent much time in the medical device industry, there are likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations…
Gleb Tsipursky
Once hailed as both an ethical mandate and a strategic necessity after the upheaval of 2020, diversity, equity, and inclusion (DEI) initiatives now face intense scrutiny and pushback. Major corporations—ranging from Walmart to Google—are quietly retreating from these programs amid escalating…
Stephanie Ojeda
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.
This article explains the difference between a deviation and a nonconformance, and why…
Akli Adjaoute
Keeping quality high in today’s fast-moving production world is a big challenge. Traditional quality checks have worked well, but they can be slow, require a lot of work, and are prone to mistakes.
AI could change this by making quality control faster, more accurate, and easier to scale. It could…
ISO
How do health and safety incidents affect your business? If a worker is injured or becomes ill, what kind of disruption does it cause? Is your productivity affected? What’s the effect on other workers in terms of workload or psychological health and well-being?
People are the foundation of every…
Chip Bell
Innovation is vital to the success of all businesses. Innovate or perish is the new mantra. Leaders must perpetually reinvent their processes, products, and services, because they typically have multiple competitors offering similar offerings. Only through innovation can most organizations…
Scott Ginsberg
Manufacturers face a critical challenge: capturing, standardizing, and scaling workforce knowledge. Skilled workers are retiring, and labor shortages are persisting. Outdated, paper-based documentation can no longer keep up. These methods create bottlenecks that slow productivity and make vital…
Gleb Tsipursky
One transformative strategy that can revolutionize how organizations embrace generative AI is peer mentoring. By leveraging the power of personal connections and shared expertise, peer mentoring accelerates learning, fosters collaboration, and fuels innovation. When mastering gen AI tools can mean…
Donald J. Wheeler
Outliers are values that don’t “fit in” with the rest of the data. These extreme values are commonly considered a nuisance when we seek to summarize the data with our descriptive statistics. This article will show how to turn these nuisances into useful information.
The earliest statistical tests…
Oliver Franz
Maybe you’re pulling reports from three different platforms, trying to reconcile numbers that don’t quite match. Maybe you’re manually copying and pasting from multiple spreadsheets, hoping you didn’t introduce any errors along the way. Or maybe you’re waiting on IT to clean up, prep data, and…
Mark Hembree
Some people don’t feel like they’re working unless their hair’s on fire. Somehow, they think it’s admirable to be feverish at a frenzied pace, breathless and full of urgency, turning tasks in record time and pushing the team to accelerate. Surely others will take notice and marvel at such hard work…
Angelina Rivera
Manufacturing is a fast-paced, constantly evolving, and dynamic environment, and the supply chain is at its heart. For small and medium-sized manufacturers (SMMs), navigating the complexities of the supply chain often feels like a high-stakes balancing act. From juggling fluctuating material costs…
Mike Figliuolo
A leader’s daily decision checklist is daunting: From hiring or firing to major business changes, every judgment call carries with it some level of risk. A bad choice could result in a toxic hire or a new product launch that crashes and burns. Perhaps more frightening is this: One poor decision…
Maria DiBari
This current job market is plagued by fake job postings that have been misleading American job seekers, wasting their time and distorting employment data. These deceptive listings—often created to collect résumés, inflate company growth metrics, or manipulate job market statistics—erode trust in…
Mike Figliuolo
We all have enemies. Some of us have many. But when we spend our time and energy focused on attacking them and counterattacking their inevitable strikes, we’re the ones losing.
In getting us to attack, our enemy has taken us away from productive pursuits. They’ve hung a dark cloud over our days.…
Saurabh Joshi Shripad
Established pharmaceutical facilities play a pivotal role in public health by ensuring the safety and efficacy of the medications they produce. This critical responsibility demands strict adherence to the Code of Federal Regulations, including 21 CFR 211.67—“Equipment cleaning and maintenance,”1,2…
Nathan Ginty
In recent years, reshoring—the process of bringing manufacturing back to the U.S.—has gained momentum. Companies are reevaluating their offshore supply chains, driven by rising costs, geopolitical risks, and supply chain disruptions. For smaller manufacturers, this shift also presents a unique…
Donald J. Wheeler
The Man of La Mancha never got to the unreachable goal—and if you’re being judged by overall equipment effectiveness (OEE), then your manager may also be dreaming an impossible dream. This column will look at problems associated with the use of OEE values.
OEE is a value often used in lean…
Harry Hertz
My story begins with Hurricane Milton, one of two tragic hurricanes to hit the west coast of Florida last year. Milton went right over Sarasota, where I live part of the year. It was a devastating storm; tree and plant debris still remain on the sides of many roads. Big root balls are still upended…
Gleb Tsipursky
New research provides a compelling analysis of the repercussions of return-to-office (RTO) policies on employee turnover, hiring, and the overall talent pool within major corporations. Using data from more than 3 million LinkedIn profiles, Mark Ma, at the University of Pittsburgh, along with other…
Nick Haase
PharmaNZ is a family-owned nutraceutical company that manufactures health supplements for the world’s leading brands. The company produces more than 250 tonnes of powder-blend products, 10 million tablets, and 70 million hard-shell capsules annually for clients worldwide. The company, founded by…
Adam Grabowski
Cash is king for manufacturers, from the owner down to the machine operators. If you visit any manufacturer, you’ll see that most have a keen eye on how everything is being used. Machines are generally only running if they are making parts; employees are typically only working if orders are coming…
Jones Loflin
I had just finished a keynote presentation and was at the book table set up by the client. Participants were invited to pick up one or more of my books, and the company would pay for them.
One excited audience member quickly made their way to the table and was perusing their possible choices. They…
Eric Linxwiler
Quality management has evolved far beyond traditional checklists and periodic inspections. For complex supply chains, quality is no longer a static endpoint. It’s a dynamic real-time process deeply interwoven with collaboration, transparency, and data-driven decision-making. As supply chains grow…
Donald J. Wheeler
In last month’s article, “ANOVA and the Process Behavior Chart,” we saw how both techniques use the same basic comparison to answer completely different questions. Here, we’ll look at a case history where both techniques were used.
A physical property of a mass-produced item was important to its…
